Keratoconus - Screening in Patients With Downs Syndrome
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 137
- 试验地点
- 1
- 主要终点
- Corneal tomography
研究概览
简要总结
The initial purpose of the study is to determine the true tomographic based age-specific prevalence of keratoconus among Danish patients with Downs Syndrome.
If, as expected, the prevalence is sizeable, the next step is to determine the optimal age for screening - considering both sensitivity and specificity as well as the need for early diagnosis in order to preserve a good visual acuity with glasses.
Lastly, the overall purpose based on the finding in the study is to evaluate if a tomographic screening program for keratoconus among patients with Downs syndrome is beneficial in Denmark.
In addition, a sub-study will further have the purpose to investigate whether patients with Downs syndrome are using optimal correction. With the purpose of generating knowledge about refraction of this specific patient group - independent of whether they are diagnosed with keratoconus or not.
The study will invite all persons with a genetic test either prenatal or postnatal showing trisomi 21 / Downs syndrom in Denmark and between the age og 10 and 20 years of age.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 10 Years 至 20 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •genetic diagnosis of trisomi 21 / downs syndrome
排除标准
- •inability to have cornea tomography performed
研究组 & 干预措施
Persons with Trisomi 21 / Downs syndrom, 10-20 years of age
The group is identified based on genetic testing either prenatal or postnatal
结局指标
主要结局
Corneal tomography
时间窗: Baseline, single time point when the study participants are included in the study
Corneal tomography to determine if the participant has keratoconus or not
次要结局
未报告次要终点